At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sotatercept (biological)
- How long the study runs
- Study runs about 91 months (dates as stated)
- About the drug or intervention
- Sotatercept — biological: Sotatercept SC injection every 3 weeks
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 815
- Started
- 2021-05-12
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary arterial hypertension
- • Phase3 - 815 participants
- • Researchers are looking for more ways to treat PAH
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pulmonary arterial hypertension
Where?
- • Cambridge - Papworth Hospital NHS Foundation Trust ( Site 1208)
- • Glasgow - Golden Jubilee National Hospital ( Site 1204)
- • London - Royal Free Hospital ( Site 1202)
- • London - Royal Brompton Hospital ( Site 1206)
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
More detail
LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ the ability to understand and provide documented informed consent
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have...
- ✓Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
- ✓Must have the ability to understand and provide documented agreement to take part
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗Did not participate in a sotatercept PAH parent study
- ✗Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
- ✗Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed...
- ✗Is a female who is pregnant or breastfeeding
See the full criteria
Where Is This Study? (7 UK sites)
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambridge CB2 0AY, United Kingdom
Golden Jubilee National Hospital ( Site 1204)
Glasgow G81 4DY, United Kingdom
Royal Free Hospital ( Site 1202)
London NW3 2QG, United Kingdom
Royal Brompton Hospital ( Site 1206)
London SW3 6NP, United Kingdom
Hammersmith Hospital ( Site 1203)
London W12 0HS, United Kingdom
Freeman Hospital ( Site 1205)
Newcastle upon Tyne NE7 7DN, United Kingdom
Royal Hallamshire Hospital ( Site 1207)
Sheffield S10 2JF, United Kingdom
